ComplianceOnline, Online Event
2013-08-06
Why Should You Attend: New medicines are developed every day to meet medical needs and improve quality of life. Analytical procedures are used to establish acceptance criteria and monitor quality of drug products. Therefore, validation becomes a critical process especially with the changes throughout the drug development process. It is important to understand validation requirements set forth by ICH and GMPs. This webinar will present the common deficiencies in relation to method validation, outline regulatory requirements and the change control process needed to stay in compliance. Learning Objectives: Upon completion of this session, attendees will understand cGMP and ICH validation requirements for analytical procedures and learn key factors that would affect validation process of analytical procedures. It would help scientists to develop process to evaluation method validation, review changes, and determine when re-validation would need to take place. It will discuss observations and infractions related to method validation. Areas Covered in the Webinar: - Deficiencies related to Method Validation.
- Factors affecting Quality of Medicines.
- Validation Characteristics
- Validation vs Re-Validation plan
- Tracking record of validation project.
- Change control of validation
Who will Benefit: - Senior management in pharmaceutical analysis
- Pharmaceutical scientists
- Analysts and lab managers
- QA managers and personnel
- Regulatory affairs
- Contract research laboratories
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